Informed consent and informed assent discussions (ICD/IAD) in pediatric clinical research are too often a less than perfect application of the ideals outlined in federal guidelines developed for the protection of human subjects. In particular, clear guidelines applying the ethical tenets governing informed consent and assent (IC/IA) in pediatric clinical research are lacking. Research evidence raises questions as to whether meaningful IC/IA are achieved in actual practice. Improving the quality of processes used to achieve IC/IA is necessary to ensure the ethical conduct of research and a positive experience for children who become research subjects and their parents/guardians. The overarching goal of this program of research is to improve the quality of the ICD/IAD for pediatric research subjects and their parents/guardians. The primary objective of this descriptive longitudinal study is to describe the informed consent and informed assent experience for adolescents, their parents/guardians and the clinical staff participating in the ICD/IAD. Specific aims include: 1) Describe the IC/IA experience for adolescents with early stage cancer and their parents/guardians considering participation in Phase II-III pediatric oncology research trials;2) Compare the qualitative (interview) and quantitative (Quality of Informed Consent Questionnaire [QuIC]) data for each child/parent dyad to examine similarities and differences;and 3) Describe the IC/IA experiences using all sources of data from adolescents, parents/guardians, and healthcare providers. A descriptive, longitudinal mixed methods design will be implemented in a pediatric oncology clinic in a large urban metropolitan setting. Step I will involve concurrent qualitative (semi-structured interviews) and quantitative (PIF, AIF, CRRRF, and QuIC) data collection approaches for adolescents, their parents/guardians, and a member of the clinical staff following the completion of the ICD/IAD for the 'parent clinical trial'. Step II will involve qualitative data collection (interviews) at approximately 6 weeks following the original ICD/IAD of the 'parent'clinical trial for adolescents and their parents/guardians. A non-probability sample of 10 adolescents (12 to <18 years of age), their parents/guardians, and 10 clinical staff participating in their ICD/IAD will be included through serial enrollment. Combined qualitative and quantitative data analyses will be guided by the following approach: Step 1: Analysis of interview transcripts via data immersion, data transformation or reduction for relevant content, identification of strips, grouping of strips with similar content, grouping strips into themes, and thematic analysis. Step 2: Analysis of the quantitative data collected in the QuIC using descriptive statistics. Adolescent and parent responses will be scored based on scoring guidelines outlined by the instrument developer, Joffe (2001). Step 3: Themes identified in the qualitative data analysis will be compared to QuIC data for similarities and differences. Step 4: The ICD/IAD will be described using all demographic (PIF and AIF) and health data sources (CRRRF) in relation to quality consent factors (QuIC) and qualitative interview themes. PUBLIC HEALTH RELEVANCE: The primary objective of this descriptive mixed methods longitudinal study is to describe the informed consent and informed assent experience primarily for adolescents, but also for their parents/guardians and the clinical staff participating in the consent and assent discussions for Phase II-III pediatric oncology clinical trials. The findings from this descriptive study will highlight relevant factors that influence the informed consent and informed assent discussions for research subjects in a variety of disciplines, especially the vulnerable population of pediatric research subjects. The end goal of improving the quality of the informed consent and assent discussion with demonstrated effective strategies will create usable evidence-based guidelines for researchers in all areas of healthcare research involving human subjects.